The present invention relates to syringe assemblies and particularly to, syringe assemblies for use in flush procedures, for vascular access devices (VAD's).
VAD's are commonly used therapeutic devices. There are two general classifications of VAD's, peripheral catheters and central venous catheters. If not properly maintained, VAD's can become occluded. To ensure VAD's are used properly and do not become occluded, standards of practice have been developed. These standards include a cleaning procedure, which is commonly referred to as a flush procedure or flushing a catheter.
VAD standards of practice usually recommend flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions and parenteral nutrition. The goal of these flush procedures is to confirm catheter patency, avoid drug incompatibilities, ensure the complete drug dose administration, prevent thrombus formation and minimize the risk of blood stream infections. Flush procedures require different types and amounts of flush solutions. The most commonly used flush solutions are saline and or heparin lock solution. The type of flush solution and amount vary depending on the specific type of catheter. Flush solution volumes between 5 and 10 ml are most common but can range from 1 to 20 ml. Flush procedures also require that care be taken to prevent blood reflux into the catheter. Reflux in I.V. therapy is the term commonly used to describe the fluid that is drawn back into the catheter after a flush procedure. The concern is that the reflux fluid contains blood or solution that could cause the catheter to occlude. To ensure that reflux does not occur, flush procedures suggest two techniques: 1) at the end of the flush solution delivery, the user maintains pressure on the syringe plunger while clamping the I.V. line; or 2) while delivering the last 0.5 ml of flush solution disconnect the syringe from the I.V. port or clamp the I.V. line. Either technique maintains positive pressure on the fluid in the VAD to prevent reflux of fluid and blood.
For flush procedures, the I.V. line refers to a system containing a VAD, tubing set with clamp and may terminate with a port or valve. The most common types of I.V. ports are covered by pierceable septums or pre-slit septums and are known in the art and sometimes referred to as “PRN” from the Latin pro re nata meaning “as the need arises”. The septum is preferably made of rubber or another elastomeric material, which permits insertion of a sharp needle cannula in order to infuse fluids or to withdraw fluids from the catheter. Upon withdrawal of the needle cannula the septum seals itself. Ports having pre-slit septums are used with blunt cannula or the frusto-conically shaped tip of a syringe barrel. The syringe tip or the blunt cannula (which is usually attached to a syringe) is gently pushed through the pre-slit septum to establish fluid communication.
I.V. valves, another type of terminal I.V. access device that does not require a needle having a sharp tip, are activated by the frusto-conically shaped tip of a syringe barrel to allow fluid communication between the interior of the syringe and the catheter. These valves may contain structure for delivering fluid from a storage compartment in the valve to the catheter, and are referred to in the art as positive displacement valves. Such a valve is taught in U.S. Pat. No. 6,206,861B1. Positive displacement valves were developed to overcome the reflux caused by the disconnection of a syringe tip or cannula from a port or valve. Unfortunately, the positive displacement valves were not designed to compensate for the worst-case syringe stopper induced reflux. When using a traditional syringe assembly containing an elastomeric stopper, the stopper is often compressed when it contacts the distal end of the syringe barrel at the completion of the flush procedure. If the user releases the pressure on the plunger after the flush solutions is delivered, the compressed stopper may expand back to its normal size drawing fluid back into the catheter. This fluid is referred to as syringe stopper induced reflux. Traditional syringe assemblies were designed to accurately deliver medications. Traditional syringe assemblies supplied by various suppliers may appear similar but can vary significantly in terms of performance especially stopper induced reflux. Because the catheter is inserted into the patient the users cannot see the reflux when it occurs and therefore cannot take corrective actions to address a potential problem.
Disconnection induced reflux and syringe stopper induced reflux would not be an issue if all users practice the positive pressure flushing techniques described hereinabove every time they flushed a VAD. However, user experience, environmental circumstance and patient condition vary significantly within the hospital setting and even more when one considers other areas that flush procedures are performed such as clinics and home care. As a result, VAD's are frequently occluded resulting in the need for additional professional time, declotting drugs, removal of catheters and new procedures to place new catheters. All of these interventions come at a cost to the healthcare system and its patients. It is desirable to have syringe assemblies that are designed for flush procedures to enhance best clinical practice. Specifically, syringe assemblies that are configured to automatically minimize or eliminate reflux without depending entirely on user technique. Further, the prior art focuses on syringe assemblies designed to deliver medications and not syringe assemblies that automatically provide additional small amount of flush solution in the I.V. line at the completion of the flush procedure.
Therefore there is a need for a simple, straight forward, automatic, easy-to-manufacture syringe assembly which helps reduce or eliminate reflux of blood into the catheter during and after the flush procedure has occurred even if recommended flush procedure techniques are not precisely followed. For example, prematurely releasing the compressive force on the plunger and/or removing the syringe from the I.V. line before it is clamped may cause reflux of blood into the catheter, thus increasing the chance of VAD occlusion.